OXYMASK
Received Sep 14, 2022
Report 8022003-2022-00002 · MDR key 15422006
Device
Product problems
- Incomplete or Inadequate Connection
- Incomplete or Inadequate Connection
Patient
Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE LOT NUMBER OF THE MASKS IS/ARE NOT KNOWN. END USER HAS STATED THAT THE TUBING HAS A RAISED RING OF MATERIAL AT THE END OF THE DETACHED TUBING. THIS DEMONSTRATES THAT THE SOLVENT PRESENCE WAS SUFFICIENT AND ABLE TO BOND THE TWO MATING COMPONENTS. THEREFORE; THE DEVICE IS ASSUMED TO BE MANUFACTURED AS INTENDED. COMPLAINT VERIFICATION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED AND THE LOT NUMBER WAS NOT PROVIDED.
Description of Event or Problem
END USER REPORTED HAVING THREE MASKS WITH TUBING THAT LATER DETACHED AT NIGHT, WHILE SLEEPING (TUBING WAS CONNECTED PROPERLY IN THE BAG AND CAME OUT AFTER). EACH MASK WITH THE DETACHMENT ISSUE WAS USED FOR ROUGHLY ONE MONTH.